Inspections, Compliance, Enforcement, and Criminal Investigations
[Federal Register: January 11, 1995 (Volume 60, Number 7)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N-0285]
Andrew Morris; Debarment Order
AGENCY: Food and Drug Administration, HHS.
SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (the act) permanently
debarring Mr. Andrew Morris, 5731 Laurel Hill Dr., Indianapolis, IN
46226, from providing services in any capacity to a person that has an
approved or pending drug product application. FDA bases this order on a
finding that Mr. Morris was convicted of a felony under Federal law for
conduct relating to the development or approval, including the process
for development or approval, of a drug product; and relating to the
regulation of a drug product under the act. Mr. Morris has notified FDA
that he acquiesces to debarment and, therefore, has waived his
opportunity for a hearing concerning this action.
EFFECTIVE DATE: May 16, 1994.
ADDRESSES: Application for termination of debarment to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Tamar S. Nordenberg, Center for Drug
Evaluation and Research (HFD-366), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-2041.
Mr. Andrew Morris, a former employee at Quad Pharmaceuticals, Inc.
(Quad), first as a bench chemist and later as a manager in Quad's
research and development department, pled guilty and was sentenced on
May 13, 1994, for making a false statement to a U.S. Government agency,
a Federal felony under 18 U.S.C. 1001, and for obstructing an agency
proceeding, a Federal felony under 18 U.S.C. 1505. The basis for this
conviction was as follows:
A. False Statement to a Federal Agency
Mr. Morris, while working as a bench chemist at Quad, made a false
representation in a certificate of analysis regarding the potency of a
particular lot of the drug azathioprine sodium, which was submitted to
FDA in support of an abbreviated new drug application (ANDA) for the
B. Obstruction of an Agency Proceeding
During an FDA audit of Quad's research and development department,
Mr. Morris gathered and destroyed certain nonsterile samples of
colistimethate sodium. These samples had previously been represented to
FDA as sterile in batch production records. These records were prepared
under Mr. Morris' supervision and were included in the ANDA for the
Mr. Morris is subject to debarment based on a finding, under
section 306(a)(2) of the act (21 U.S.C. 335a(a)(2)), that he was
convicted of felonies under Federal law for conduct relating to the
development, approval, and regulation of a drug product. Mr. Morris'
false statements in documents used to support the ANDA's for the two
Quad drug products relate to the development or approval of a drug
product because FDA relies on the safety and efficacy data and
information in the ANDA's in making its decisions whether to approve
drug products. Mr. Morris' false statements and destruction of drug
samples relate to the regulation of drug products because FDA's
regulatory decisions about Quad drug products may have been affected by
In a letter received by FDA on May 16, 1994, Mr. Morris notified
FDA of his acquiescence to debarment, as provided for in section
306(c)(2)(B) of the act. A person subject to debarment is entitled to
an opportunity for an agency hearing on disputed issues of material
fact under section 306(i) of the act, but by acquiescing to debarment,
Mr. Morris waived his opportunity for a hearing and any contentions
concerning his debarment.
II. Findings and Order
Therefore, the Interim Deputy Commissioner for Operations, under
section 306(a) of the act, and under authority delegated to her (21 CFR
5.20), finds that Mr. Andrew Morris has been convicted of a felony
under Federal law for conduct relating to the development or approval,
including the process for development or approval, of a drug product
(21 U.S.C. 335a(a)(2)(A)); and relating to the regulation of a drug
product (21 U.S.C. 335a(a)(2)(B)).
As a result of the foregoing findings and based on his notification
of acquiescence, Mr. Andrew Morris is permanently debarred from
providing services in any capacity to a person with an approved or
pending drug product application under section 505, 507, 512, or 802 of
the act (21 U.S.C. 355, 357, 360b, or 382), or under section 351 of the
Public Health Service Act (42 U.S.C. 262), effective May 16, 1994, the
date of notification of acquiescence (21 U.S.C. 335a(c)(1)(B) and
(c)(2)(A)(ii) and 21 U.S.C. 321(ee)). Any person with an approved or
pending drug product application who knowingly uses the services of Mr.
Morris, in any capacity, during his period of debarment, will be
subject to civil money penalties. If Mr. Morris, during his period of
debarment, provides services in any capacity to a person with an
approved or pending drug product application, he will be subject to
civil money penalties. In addition, FDA will not accept or review any
ANDA's submitted by or with the assistance of Mr. Morris during his
period of debarment.
Any application by Mr. Morris for termination of debarment under
section 306(d)(4) of the act should be identified with Docket No. 94N-
0285 and sent to the Dockets Management Branch (address above). All
such submissions are to be filed in four copies. The public
availability of information in these submissions is governed by 21 CFR
10.20(j). Publicly available submissions may be seen in the Dockets
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
Dated: January 4, 1995.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 95-695 Filed 1-10-95; 8:45 am]
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